Topical recombinant human thrombin in surgical hemostasis

Area of Science:

• Surgical Hemostasis
• Biotechnology
• Pharmacology

Background:

• Achieving hemostasis is critical in all surgical procedures.
• Traditional methods like ligation and electrocautery are insufficient for diffuse raw surface bleeding.
• Topical thrombin aids in controlling intraoperative and perioperative hemorrhage.

Purpose of the Study:

• To evaluate the efficacy and safety of recombinant human thrombin (rhThrombin) for surgical bleeding.
• To compare rhThrombin with existing topical thrombin preparations.
• To assess the risk of immunogenicity and viral transmission associated with rhThrombin.

Main Methods:

• Review of three randomized controlled trials (RCTs) assessing rhThrombin efficacy.
• Comparison of rhThrombin's hemostatic effect, safety profile, and immunogenicity against bovine and plasma-derived human thrombin.
• Analysis of economic parameters and risk of adverse events, including antithrombin antibody development.

Main Results:

• rhThrombin demonstrated efficacy in achieving hemostasis within 10 minutes for mild to moderate diffuse bleeding.
• rhThrombin is as effective as bovine thrombin.
• rhThrombin presents a significantly lower risk of immunogenicity and limited risk of viral transmission or antibody development.

Conclusions:

• rhThrombin is an effective option for managing diffuse surgical bleeding.
• rhThrombin offers a favorable safety profile, comparable efficacy, and reduced immunogenicity compared to other topical thrombin products.
• The use of rhThrombin may be supported over bovine- and plasma-derived thrombin due to its safety and efficacy profile.